NCT04017702

Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Respiratory volume monitor (RVM) (ExSpiron) is superior to continuous pulse oximetry in detection of postoperative respiratory depression in high risk patients.

Detailed description

Aims are to: 1) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous pulse oximetry 2) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous respiratory volume monitor (RVM) (ExSpiron) 3) Assess the agreement between the continuous pulse oximetry and continuous respiratory volume monitor (RVM) (ExSpiron) in detection of postoperative respiratory depression in high risk patients

Conditions

• Respiratory Depression

Interventions

Type	Name	Description
DEVICE	Expiron respirator	Respiratory volume monitor (RVM) (ExSpiron, is a non-invasive FDA approved device that monitors minute ventilation (MV) and provides an early indication of respiratory status in non-intubated patients. The system consists of a lightweight monitor, a patient cable, and a disposable electrode PadSet, which detects changes in breathing.

Timeline

• Start date: 2018-06-20
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2019-07-12
• Last updated: 2022-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study